VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Primary DI

29418000002cxINC

Basic UDI-DI Code

2321183242cxINC6J

Reference

2cxINC01

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

2cureX A/S

As part of the IndiTreat® CRC testing, IndiNet CRC is an in vitro diagnostic software used to determine tumor growth inhibition induced by specific antineoplastic drugs of patient derived 3D microtumors from fresh non- fixated samples of colorectal cancer (CRC) tissue. IndiNet CRC is image analysis software, designed to identify and quantify living tumoroids based on bright field images and images of tumoroids stained with IndiTreat® Live Stain. Patient specific tumor growth inhibition by effective cancer drug regimen is derived using the IndiTreat® Live Stain assay in combination with the IndiNet CRC algorithm and the results are compared with a reference database. This information can be used to classify the tumor sensitivity / susceptibility to treatment with a variety of antineoplastic drugs and may be used by physicians for treatment planning. IndiNet CRC is intended for use by qualified personnel trained by 2cureX. Users should have a thorough understanding of IndiTreat® CRC testing. Familiarity with basic image analysis tools and concepts is recommended.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).